Z-0407-2017Class II

Access Ostase Calibrators, Catalog No. 37305, B83876

Name: Z-0407-2017 Access Ostase Calibrators, Catalog No. 37305, B83876
Creator: Beckman Coulter Inc.
Published: 2016-10-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-10-24 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the... on 2016-10-24. FDA classified it as Class II and gives the reason as "Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0407-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-24
Posted: 2016-11-15
Terminated: 2018-02-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
Product code: JIS Calibrator, Primary
Reason for recall: Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated October 24, 2016 was sent to all their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding the notice are instructed to contact Customer Technical Support Center at http://www.beckmancoulter.com, (800) 854-3633 in US and Canada, and to contact local Beckman Coulter representative if outside of US and Canada.
Quantity in commerce: 357 kits total (94 kits in US)
Distribution: US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL. Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.
Product codes and lots: 623207 626000 628294 628296

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0407-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0407-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-14
Z-0408-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-14

Product code JIS

K994278Class IIAccess Ostase Immunoenzymetric AssayBeckman Coulter, Inc. / cleared 2000-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)